The following data is part of a premarket notification filed by Microcurrent Research, Inc. with the FDA for Acusource 600 For Use With Tmj Electrode.
Device ID | K901902 |
510k Number | K901902 |
Device Name: | ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE |
Classification | Stimulator, Muscle, Powered, Dental |
Applicant | MICROCURRENT RESEARCH, INC. 1440 WHALLEY AVE. STE 224 New Haven, CT 06515 |
Contact | Paul Davis |
Correspondent | Paul Davis MICROCURRENT RESEARCH, INC. 1440 WHALLEY AVE. STE 224 New Haven, CT 06515 |
Product Code | NUW |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-27 |
Decision Date | 1990-10-09 |